MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE FIXED BEARING; PROSTHESIS, KNEE

Catalog Number 42512200611

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Product expected, not yet received.

Event Description

It was reported that the surgeon was unable to get the articular surface to engage with the tibial baseplate despite following the surgical technique.Surgery was delayed by ten to fifteen minutes while a replacement item was delivered.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.Concomitant medical products: femur cemented cruciate retaining (cr) standard left size 10 lot# 62575604.Item# 42502606801, tibia cemented 5 degree stemmed left size g lot# 63404221 item# 42532007901, all-poly patella cemented 35 mm diameter lot#63538185 item# 42540200035, articular surface fixed bearing ultracongruent (uc) left 11 mm height lot# 63044556 item# 42512200611, 2.5 mm female hex screw 25 mm length lot# 63649495 item# 42509902525.The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Compatibility check noted no issues.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned articular surface show that the device is nicked and gouged on both the superior and inferior side.Additionally, the dovetail feature is flared all around.Dimensions of the medial lateral width, anterior-posterior medial condyle width, and anterior-posterior lateral condyle width were measured and were found to be within print specifications.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE FIXED BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6716612
• MDR Text Key: 80119176
• Report Number: 0001822565-2017-04878
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 42512200611
• Device Lot Number: 62932150
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN PERSONA TIBIAL TRAY